Kornimate/medical-research-clean huggingface dataset:
conservative treatment of esotropia in children up to 3 years old

Conditions: Esotropia

Summary: the objective of this prospective study is the treatment of esotropia by prescribing the full precise optical correction of refractive errors in children up to 3 years old.

this investigation includes children with esotropia associated with hyperopia, hypermetropic astigmatism, myopia, myopic astigmatism and minor ametropias. all children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 dpt to achieve maximal clear image on the retina of both eyes.if necessary, direct occlusion or penalization were administered to the children. the investigators suggest that this approach will give good results in the treatment of esotropia.

Eligibility criteria:
inclusion criteria: * within the age of 3 months to 3 years (inclusive infantile esotropia) * patients with constant or periodic esotropia and with revealed angle of deviation 5 degrees or over by hirschberg test * patients with refractive errors (inclusive minor ametropias from 0.5 dptr) exclusion criteria: * age above 3 years * patients with neurological diseases and paralytic strabismus
carotid artery implant for preventing stroke in atrial fibrillation patients taking oral anticoagulants

Conditions: Atrial Fibrillation; Stroke

Summary: this study will assess the safety and performance of the vine™ embolic protection system (embolic filtering device) in atrial fibrillation (af) patients on top of oral anticoagulants (oac), and remain at high risk for stroke recurrence. all patients will receive bilateral implants in the common carotid arteries

the vine™ filter (vine™ or implant) is a permanent carotid filter designed for stroke prevention in af patients taking oac at high stroke risk (cha2ds2-vasc ≤ 4 and stroke history). this patient population accounts for \~20% of the entire af population, which is \~300k/year in the united state and eu. the implant is designed to exclude emboli \> 1.4mm in size from reaching the anterior circulation. in af patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the circle of willis, mainly m1-2, and rarely a1-2. the diameter of these branches, in the majority of cases, is \> 1.5 mm

Eligibility criteria:
inclusion criteria: * documented af * cha2ds2-vasc score ≥ 4 and history of ischemic stroke (including tia with positive neuro-imaging) * no contra-indication for patient to receive an oac, either vitamin k antagonist (vka) or novel oral anticoagulant (noac) for the duration of the study * age \> 50 years * maximal (systolic) cca diameter range: ≥ 4.8mm and ≤ 9.8mm * cca accessibility: up to 40mm from skin to cca center, safe approach * implantation segment free of atherosclerotic disease as determined by ultrasound imaging * patient is able and willing to provide informed consent exclusion criteria: * evidence of carotid stenosis \> 30% \[cca, internal carotid artery (ica), or external carotid artery (eca)\] * evidence of carotid dissection * pre-existing stent(s) in cca * female who is pregnant or who is planning to become pregnant during the course of the study * life expectancy of less than two years * active systemic infection * known sensitivity to nickel or titanium metals, or their alloys * known hereditary or acquired coagulation disorders * any planned surgical or endovascular treatment within 30 days after the implantation procedure * a co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments\* current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day) * active participation in another investigational drug or device treatment study * inability to complete all scheduled follow-up * any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study * history of intracerebral hemorrhage (ich) and/or hemorrhagic stroke * event of stroke/tia in the past 14 days

Keywords: af stroke filter emboli carotid oac
study of bortezomib (btz) treatment on mantle cell lymphoma (mcl) in chinese participants

Conditions: Lymphoma, Mantle-Cell

Summary: the purpose of the study (retrospective and prospective) is to describe participant and disease characteristics and treatment pattern of bortezomib treated mantle cell lymphoma (mcl) participants in china.


Eligibility criteria:
inclusion criteria: * participants that have been hospitalized for mcl after january 1st 2009. * biopsy proven mcl as evidenced by histology with either immunohistochemistry (ihc) or t(11,14) translocation * retrospective group: participants who have finished btz treatment before the study initiation as judged by participating site physician * if participant isn't accessible for oral or written informed consent, icf can be waived after approved by the irb * prospective group: participants who are on btz at the time of study initiation or start btz after study initiation exclusion criteria: * participants with documented diagnosis of other cancers prior to or at the presence of the diagnosis of mcl * participants enrolled in interventional clinical trials of btz or any other drug for mcl * prospective group: participants with contraindication listed in the prescribing information of btz
the psychological impact of mindfulness intervention to anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament (Acl) Reconstruction

Summary: anterior cruciate ligament (acl) reconstruction surgery is a common procedure performed by orthopedic surgeons. postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. these factors influence the recovery and return to sports capabilities of acl patients. according to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. psychological factors during the recovery process may explain this disparity. acl injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. a study by lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. this suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports. mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. good sleep quality contributes to emotional stability and physical recovery. even short daytime naps can be beneficial for athletes. a review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep. therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after acl reconstruction.


Eligibility criteria:
inclusion criteria: * within the first month after acl reconstruction without mindfulness practice experience exclusion criteria: * below 18 years old, previous exposure to mindfulness intervention

Keywords: mindfulness napping acl injury return-to-sport polysomnography
intimate partner violence as a risk factor for venous thromboembolism in women

Conditions: Venous Thrombosis

Summary: the frequency of violence against women, or intimate partner violence (ipv) is more and more underlined and recognized as a cofactor favoring certain somatic and psychic pathologies. however, its incidence in patients with venous thromboembolism (vte) is unknown and its status as a risk factor is still elusive and ambiguous. investigators therefore conducted a matched case-control study consisting of women taking combined oral contraceptives (coc) who were investigated and followed up between 2010 and 2020. the cases are the patients investigated for their first venous thromboembolic event, the controls were women free of thrombosis who had regular gynecological checkups. case-control pairs were matched on region of residence, age (+/- 2 years), duration of coc intake (+/- 4 months), coc type (2nd, 3rd or 4th generation).


Eligibility criteria:
* patients: first venous thromboembolic event associated with the intake of combined oral contraceptives * controls: regular follow-up of their combined oral contraception * patient-control pairs matched on region of residence, age, duration of coc intake, type of coc.
inflammatory parameters as predictive factors for complicated appendicitis

Conditions: Acute Appendicitis

Summary: acute appendicitis is a major cause of acute abdomen. although its diagnosis is clinical, it is often supported by complementary diagnostic tests. sometimes, delay in diagnosis can lead to worsening of the clinical picture, resulting in a complicated acute appendicitis. some series have studied some clinical and analytical parameters as possible predictors of complicated acute appendicitis. a retrospective analysis of patients admitted for acute appendicitis and undergoing appendectomy between january 2014 and december 2017 was performed in order to assess the possible existence of preoperative analytical predictive factors for complicated acute appendicitis (such as leukocytosis, c-reactive protein and ratio between neutrophils and lymphocytes).


Eligibility criteria:
inclusion criteria: * all patients admitted for acute appendicitis exclusion criteria: * excluded if no existence of dosing of all the inflammatory parameters cited above
part a: in patients with chronic liver diseases, laennec (human placenta hydrolysate) is to assess safety and tolerability after the doses of doses. part b: part a, it is to determine the optimal dose by evaluating two capacity and placebo groups.

Conditions: Chronic Liver Disease

Summary: part a: in patients with chronic liver diseases, laennec (human placenta hydrolysate) is to assess safety and tolerability after the doses of doses. part b: part a, it is to determine the optimal dose by evaluating two capacity and placebo groups.


Eligibility criteria:
inclusion criteria: 1. at the time of screening, 18 or 75 years 2. those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease and have persisted for more than 6 months 3. those who are 1.5 times (60 iu/l) of the alt level of baseline (60 iu/l) 4. a person who can complete the signature agreement and compliance the requirements for clinical trials. exclusion criteria: 1. liver function abnormalities caused by the following cause disease: viral hepatitis, biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive 2. drug allergic symptoms (oscillation, heat, itching) 3. those with systemic infection (including tuberculosis) 4. if the test person judges that it is difficult to participate in clinical trials due to the next disease: cirrhosis of child c or higher, cirrhosis with edema and plural, malignant tumors, severe disorders, severe renal disorders, severe cardiovascular disease, severe nerve mental disorders, preferences, etc. 5. those who have experienced use of human -derived medicines within 6 months before selecting a test subject 6. those who have received other clinical drugs within 3 months before selecting a test subject 7. magnetic resonance spectroscopy (mrs) is impossible 8. a person who does not perform appropriate contraception as a pregnant woman, a nursing or a woman of childbearing age (effective contraception method: barrier methods using infertility surgery, uterine device, condom, killer) 9. those who cannot inject intravenous infusions 10. those who judged that other testors were inappropriate as clinical trials
autologous human schwann cells in peripheral nerve repair

Conditions: Peripheral Nerve Injuries

Summary: the purpose of this study is to assess the safety of autologous human schwann cell (ahsc) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (pni). for humans with acute severe pni, the hypothesis is that augmentation of nerve autograft repair with ahscs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.


Eligibility criteria:
inclusion criteria: * persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year; * peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings; * between the ages of 18 and 65 years at last birthday; exclusion criteria: * persons unable to safely undergo an mri (may include persons with an implanted device or metallic fragments which may interfere with mri safety); * persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve); * persons with severe peripheral nerve injury gap length \> 10 cm in length; * persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; * pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation; * presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study; * history of active substance abuse; * persons allergic to gentamicin; * persons who test positive for hiv or hepatitis b or c virus;
dexamethasone palmitate for ponv after craniotomy

Conditions: Postoperative Nausea and Vomiting

Summary: dexamethasone is almost one of the most commonly used drugs for postoperative nausea and vomiting (ponv) prevention. however, ponv is still a complex problem to be solved; for example, even with preoperative dexamethasone administration, there are still some patients undergoing craniotomy still experience ponv within 24 hours postoperatively. compared to dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, 2-5 times that of traditional water-soluble dexamethasone, with fewer adverse effects. this trial aims to assess the effect and safety of preoperative dexamethasone palmitate on ponv after craniotomy.


Eligibility criteria:
inclusion criteria: * aged 18 to 65 years; * providing written informed consent; * perform elective craniotomy undergoing general anesthesia. exclusion criteria: * known to be allergic to dexamethasone; * any systemic glucocorticoids within 3 months before trial entry; * history of severe heart disease, liver/kidney failure, or systemic rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, et al); * cognitive impairment or severe mental illness; * uncontrolled diabetes or infectious diseases; * pregnancy or breastfeeding.
assessment of cardiac function, microvascular function and cardiac perfusion in different disease stages of hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy; Hypertrophic Cardiomyopathy, Obstructive

Summary: hypertrophic cardiomyopathy (hcm) is a genetic disorder characterized by asymmetric hypertrophy of the heart in absence of loading conditions like hypertension. the genetic mutation underlying hcm sets in motion a cascade of functional and metabolic changes ultimately leading to disease. hcm patients often have microvascular dysfunction and myocardial perfusion deficits, of which the aetiology has not been elucidated. whether these changes are secondary to remodelling or primarily caused by endothelial dysfunction is unclear. as the pathomechanism of hcm is thought to be a cascade of changes, it is important to gain more insight in the perfusion and endothelial function changes throughout different stages of disease: no phenotype, mild phenotype, and advanced hcm phenotype. in this study we aim to investigate these changes in the two most common genetic mutations.


Eligibility criteria:
inclusion criteria: one of below: * mybpc3 mutation carrier * myh7 mutation carrier * genotype-negative first degree relative of a mybpc3 or myh7 mutation carrier all of the following criteria: * for the mutation carrier group: ≥18 years old * for the genotype-negative group: ≥30 years old mybpc3 and myh7 mutation carriers will be designated to one of three groups based on their maximum wall thickness, measured by echocardiography and mri: * no phenotype: mwt \<12mm * mild phenotype: mwt ≥12 until \<15mm * hcm phenotype: mwt ≥15mm exclusion criteria: * ≥70 years old * insulin-dependent diabetes mellitus * pregnancy * smoking * claustrophobia * pacemaker/icd * renal insufficiency \<30 gfr * hypertension (systolic \>140mmhg or diastolic \>90mmhg) * for the genotype negative group, no phenotype group, and mild phenotype group: the use of blood pressure medication (diuretics, beta-blockers, ace-inhibitors, angiotensin ii receptor blockers, calcium channel blockers, alpha blockers) * for the hcm phenotype group: when it is unsafe to withhold from blood pressure medication (as specified above) for two days, as assessed by their own cardiologist * left ventricular outflow tract gradient \> 50mmhg * aortic valve disease * left bundle branch block * (history of) obstructive coronary artery disease * chronic atrial fibrillation * hormone replacement therapy * second or third-degree av-block, sick-sinussyndrome, prolonged qt-interval * asthma and other obstructive pulmonary diseases * previous adverse reaction to adenosine or dotarem

Keywords: hypertrophic cardiomyopathy perfusion endothelial function
ats 3f enable(tm) aortic bioprosthesis, model 6000

Conditions: Heart Valve Diseases

Summary: this is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ats 3f enable aortic bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. the enable aortic valve is an equine pericardial stented bioprosthesis.

the ats 3f enable aortic bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. for these patients, there are a number of widely accepted prosthetic heart valves in use.

Eligibility criteria:
inclusion criteria: * the patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (the three remaining valves must be of native tissue). * the patient is geographically stable and willing to return to the implant site for follow-up visits. * the patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study. * if this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure. exclusion criteria: * the patient requires replacement of two or more valves. * the patient is \< 20 years of age. * the patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 24 months. * the patient is an intravenous drug and/or alcohol abuser. * the patient presents with active endocarditis or other systemic infection. * the patient has had previous valve replacement surgery, including previous implant and then explant of the ats 3f enable aortic bioprosthesis (model 6000) or placement of a rigid annuloplasty ring in the mitral position. * the patient is participating in concomitant research studies of investigational products. * the patient presents with dilatation of the ascending aorta, marfan syndrome, ehlers-danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging. * the patient has chronic renal failure.

Keywords: diseased heart valve, replacement, aortic
evaluation of the global auditory nerve activity for exploration of hearing in humans

Conditions: Hearing Loss

Summary: to date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. this measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. this can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. in this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. we expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.


Eligibility criteria:
inclusion criteria: * 18 - 80 years ( inclusive borders) * patient having to undergo surgery at the level of the ponto-cerebellar angle (microvascular decompression, vestibular neurotomy, tumor resection of the meningioma type or schwannoma) and * unaffected by neuro-sensory hearing loss, defined by mean auditory thresholds of less than 20 db in tone audiometry in bone conduction on the side of the ear to be operated (n = 15, group 1) or * showing mild to moderate hearing loss defined by average hearing loss (average of 500, 1000, 2000 and 4000 hz thresholds) greater than 20 db and less than 55 db in air conduction threshold tone audiometry (n = 15 group 2). * voluntary subjects to participate in the study, * subjects having signed written consent to participate in the study, * easily accessible topics. exclusion criteria: * subjects unable to understand the nature and goals of the study and / or having difficulty communicating with the investigator, * subjects refusing to participate, subjects whose free and informed consent has not been sought, subjects for which a consent form has not been signed, * subjects for whom there is a contraindication to general anesthesia, * subjects with a central neurological pathology that can disrupt electrophysiological recordings * not affiliated to a french social security scheme or not benefiting from such a scheme, * majors protected by law, * pregnant women, * deprived of liberty by judicial or administrative decision, * infectious or inflammatory pathology of the middle ear.

Keywords: evoked auditory nerve activity hearing loss tinnitus